Ozra Tabasi*, Mahdi Roohi Razlighi and Mohammad Ali Darbandi
Background: Ferric carboxymaltose (FCM) formulation consists of iron–carbohydrate nanoparticles that iron– oxyhydroxide as a core is covered by carbohydrate shell. The present work provides an improved synthesis process of FCM as an intravenous iron active pharmaceutical ingredient.
Methods: Water soluble FCM complex was prepared from the reaction of ferric hydroxide precipitation with an aqueous solution of oxidized maltodextrin (MD) at optimum temperature and pH conditions. A systematic approach was followed to obtain the optimal weight ratio of the maltodextrin/ferric chloride for FCM synthesis process with suitable-sized nanoparticles. Physical characterization of new synthesized ferric carboxymaltose (FCM-NP) was performed and established its equivalency with the reference product (Ferinject).
Results: The size distribution of the whole nanoparticles determined by dynamic light scattering (DLS) was in the range of 15-40 nm with the average particle size 26 ± 6.6 and 25.8 ± 4.9 for FCM-NP and Ferinject, respectively. X-ray diffraction (XRD) results of FCM-NP and Ferinject indicated the Akaganeite structure of iron-oxyhydroxide. The iron content of particles (cores) measured by Atomic absorption spectroscopy (AAS) was almost equal for two formulations. The Fourier transform infrared (FTIR) spectra of Ferinject and FCM-NP were approximately similar.
Conclusion: Various analytical methods including FTIR spectroscopy, XRD analysis, DLS technique, TEM, and AAS were employed. It was observed that the specifications of FCM-NP obtained by these analyses, were almost identical to those of Ferinject. Accordingly, the two formulations were considered comparable.
ferric carboxymaltose, maltodextrin, synthesis, Ferinject, pharmaceutic
Research and Development unit, Nafas Zist Pharmed Pharmaceutical Company, Science and Technology Park of Islamic Azad University, Tehran, Research and Development unit, Nafas Zist Pharmed Pharmaceutical Company, Science and Technology Park of Islamic Azad University, Tehran, Research and Development unit, Nafas Zist Pharmed Pharmaceutical Company, Science and Technology Park of Islamic Azad University, Tehran